EyeWorld Weekly Update, September 8, 2017

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September 8, 2017
Volume 23 , Number 31

Acquisition of TearScience completed

Johnson & Johnson Vision (Santa Ana, California) announced the completion of the acquisition of TearScience (Morrisville, North Carolina). TearScience focuses on the treatment of meibomian gland dysfunction.

Phase 3 trial for netarsudil/latanoprost initiated in Europe

Patient dosing has begun in Mercury 3, a European Phase 3 trial for netarsudil 0.02%/latanoprost 0.005% (Roclatan, Aerie Pharmaceuticals, Irvine, California), a once-daily eye drop that has been shown in U.S. clinical trials to lower IOP in open angle glaucoma and ocular hypertension patients. Mercury 3 has been set up to facilitate regulatory approval and commercialization in Europe and is not needed for approval in the U.S., according to a company press release. Aerie estimates that 500 patients will enroll in Mercury 3, a two-arm, 6-month safety trial with a 90-day interim efficacy readout that compares once-daily Roclatan for non-inferiority to Ganfort, a fixed-dose combination IOP-lowering agent in Europe. Each arm will be dosed once a day in the evening. The trial will primarily take place in the U.K., France, Germany, Italy, Spain, and Belgium. Topline 90-day efficacy data are expected to be ready in early 2019. In the U.S., Aerie expects to file a New Drug Application with the U.S. Food and Drug Administration (FDA) for Roclatan in the first half of 2018.

Study: Patients could easily monitor IOP on their own

In an observational study, most patients could perform self-tonometry, according to Savva Pronin, BSc, and coauthors. Researchers assessed IOP with Goldmann applanation tonometry and a rebound tonometer. Patients received standardized self-tonometry training and measured their own IOP under observation. The average patient age was 67.5 years. The study of 100 patients found that 73% were able to perform self-tonometry using a rebound tonometer and obtain IOP measures within 5 mm Hg of a clinician. The rebound tonometer was, on average, 2.66 mm Hg lower than Goldmann applanation tonometry. Seventy-one percent of patients thought that self-tonometry was easy, and 92% said it was comfortable. The majority of patients said they would feel fine performing self-tonometry in the future. The research appears in JAMA Ophthalmology.

Orphan drug designation given for agent that treats Usher syndrome

Drug candidate QRX-421 (ProQR, Leiden, the Netherlands) to treat Usher syndrome has received an orphan drug destination from the U.S. FDA and the European Medicines Agency. There are no therapies currently available to treat vision loss associated with Usher syndrome type 2. Preclinical data for QRX-421 related to patient fibroblasts and the optical cup model were presented earlier this year at the Association for Research in Vision and Ophthalmology annual meeting. The company's second candidate for Usher syndrome, QRX-411, received orphan drug designation in July.

RESEARCH BRIEFS

  • In short eyes, slightly myopic refractive prediction errors were found with the Hoffer Q and Holladay 2 formulas, according to Sabite Gökce, MD, and co-researchers. They investigated the accuracy of seven IOL calculation formulas for the prediction of a refractive outcome in eyes with axial lengths equal to or less than 22 mm. The retrospective case series included 86 eyes from 67 patients. The Barrett Universal II, Haigis, Hill-RBF, Hoffer Q, Holladay 1, Holladay 2, and Olsen formulas were evaluated. Refractive prediction error was calculated as the difference between the postoperative refraction and the refraction predicted by each formula. The Hoffer Q and Holladay 2 produced myopic refractive prediction errors of -0.22 D and -0.23 D, respectively. The Olsen formula produced a hyperopic refractive prediction error of +0.27 D (all P<.05). No statistically significant differences in the median absolute error were found when the mean numerical refractive prediction error was adjusted to zero. The research appears in the Journal of Cataract & Refractive Surgery.
  • A relevant change in the anterior to posterior corneal curvature relationship was induced by Descemet's membrane endothelial keratoplasty (DMEK) and should be considered when calculating IOL power to avoid hyperopic refractive surprises, according to Maged Alnawaiseh and coauthors. Ray tracing was used to calculate IOL power for all patients (42 eyes of 33 patients), with a goal of postoperative emmetropia. Using four third-generation formulas (SRK-T, Hoffer-Q, Holladay-1, and Haigis) IOL calculation was performed, and the residual refractions for the individual target IOL were compared and analyzed. The highest mean difference in residual refraction between the target IOL measured by ray tracing and that calculated with third-generation formulas was found for the Haigis formula. The lowest mean difference was found for the SRK/T formula. The study is published in BMC Ophthalmology.
  • There is a 5.5% risk of retinal detachment in the first 10 years post-cataract surgery in children, according to Sumita Agarkar, MS, and co-researchers. Their retrospective case series included 481 eyes of 295 children younger than 16 with no other ocular and systemic abnormalities. The median follow-up was 66 months. Twelve eyes (nine children) developed retinal detachment after cataract surgery at a median time of 70 months. A retinal break associated with the induction of posterior vitreous detachment was the most common cause of retinal detachment. The risk for retinal detachment increased in patients who were male, myopic, and intellectually disabled. More long-term follow-up studies are needed, the researchers concluded. The study appears in Ophthalmology.
  • An accelerated corneal crosslinking (CXL) approach was equally effective at treating pediatric keratoconus compared to a conventional approach, reported Philipp Baenninger, MD, and co-researchers. They compared visual and topographic outcomes 1 year after conventional CXL compared with accelerated CXL. Seventy-eight eyes (58 patients) with topography-confirmed, progressive keratoconus and a corneal thickness of 400 microns or greater at the time of surgery were included in the study. Half of the eyes received conventional CXL and half received accelerated CXL. The treatment failure rate was defined as the percentage of eyes with an increase in Kmax of 1 D or more during follow-up. A treatment failure rate was observed in 23.1% of eyes in the conventional group and 15.4% of eyes in the accelerated group. One eye in the conventional treatment group had an adverse event (a loss of two or more Snellen lines of best corrected visual acuity compared with baseline). The research appears in the American Journal of Ophthalmology.

  • PRODUCT NEWS
  • PhysIOL (Liege, Belgium) gained CE approval in Europe for its FineVision (Pod F GF) trifocal hydrophobic glistening-free IOL.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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